Clinical and Functional Outcome of the GEMINI SL Fixed Bearing PS Knee Prosthesis

Recruiting now

Conditions studied: Osteoarthrosis of Knee

In brief

This is a prospective, multicenter, observational study with a planned follow-up period of 10 years to confirm the safety and performance of the GEMINI SL Fixed Bearing PS knee prosthesis in longterm follow-up under routine conditions. Primary outcome of the study is the 10-year survival rate of the GEMINI SL Fixed Bearing PS knee prosthesis with revision for any reason as the endpoint.

Key facts

Study ID

NCT04858347

Run by

Waldemar Link GmbH & Co. KG

People needed

350

Starts

2019-07-04

Expected to finish

2035-10-01

Last updated by the study team

2023-01-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed patient informed consent
• Implantation of a GEMINI SL Fixed Bearing PS knee prosthesis
• Age between 18 and 80 years

You may not qualify if…

• Body Mass Index (BMI) > 40 kg/m²
• Foreseeable life expectancy under 5 years
• Comorbidities and known medical circumstances which would affect the clinical or functional outcome after implantation of the knee prosthesis (e.g. neurological or musculoskeletal diseases) at the time of implantation
• Patient who is mentally not able to understand the study and the study conduct
• Patients who will be foreseeable non-compliant to the planned routine interventions and study related follow-ups
• Prisoner
• Pregnant women

Where it is running

• Centro Medico Imbanaco Sede Principal — Cali, Valle del Cauca Department, Colombia (enrolling)

Full record on ClinicalTrials.gov

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